Partial – Talk Bio

FDA places partial clinical hold on Merck and Daiichi Sankyo’s I-DXd lung cancer trial after interstitial lung disease deaths

1 month ago talkbio0Tagged Antibody-Drug Conjugates, Clinical Trials, Daiichi, Deruxtecan, grade 5 ILD, I-DXd, IDeate-Lung02, ifinatamab, Lung Diseases, Interstitial, Merck, Partial, Sankyo, Small cell carcinoma of lung, United States Food and Drug Administration

FDA partial clinical hold; ifinatamab deruxtecan; I-DXd; IDeate-Lung02; Merck; Daiichi Sankyo; small cell lung cancer; interstitial lung disease; grade 5 ILD; antibody-drug conjugate; clinical trial deaths

FDA Places Partial Clinical Hold on BioNTech’s Anti-CTLA-4 Antibody Trial

1 year ago talkbio0Tagged Antibodies, BioNTech, Clinical Trials, Partial, Study on Hold, United States Food and Drug Administration

BioNTech, FDA, partial clinical hold, anti-CTLA-4 antibody, clinical trial, OncoC4

PTC Therapeutics Reports Positive Phase II Huntington’s Disease Data, FDA Lifts Partial Clinical Hold

2 years ago talkbio0Tagged clinical trends, factor IX, Huntington 's disease, mutant huntingtin protein, Partial, Phase II, PTC518, Safety, Study on Hold, tolerability, United States Food and Drug Administration

PTC Therapeutics, Huntington’s disease, Phase II data, FDA, partial clinical hold, PTC518, mutant huntingtin protein, clinical trends, safety, tolerability.

FDA Places Partial Clinical Hold on Zentalis’ Azenosertib Cancer Studies Following Two Sepsis Deaths

2 years ago talkbio0Tagged cancer studies, Cessation of life, Clinical Trials, Inhibitor, Partial, patient safety, Septicemia, Study on Hold, United States Food and Drug Administration, WEE1 gene, Zentalis

Zentalis Pharmaceuticals, azenosertib, FDA, partial clinical hold, cancer studies, sepsis deaths, WEE1 inhibitor, clinical trials, patient safety